Exculpatory Language and Informed Consent无罪的语言和知情同意.pptVIP

Greg E. Manship, M.Div., MT(ASCP), CIM, CIP IRB Coordinator, University of Indianapolis Co-Vice Chair, Community Health Network IRB “Exculpatory” from “exculpate” “Exculpate” (Latin) ex (from) + culpa (blame) “to clear from alleged fault or guilt”* *Merriam-Webster’s Online Dictionary (/dictionary/exculpate) 45CFR46.116 and 21CFR50.20 “No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subjects legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.” “Narrow Interpretation” “Broad Interpretation” “. . . the subject or the representative is made to waive . . .or releases . . . ” Restricts meaning to etymological definition of “to clear from blame or fault” Limits prohibition to statements about release from liability Meaning limited to not holding researchers at fault for wrongful acts “ . . . subject or the representative is made to waive or appear to waive any of the subjects legal rights, or releases or appears to release . . .” Researchers many NOT use language whereby a subject waives actually or apparently any legal rights The prohibition of exculpatory language is to preclude exploitation of voluntariness and vulnerability of participation in research. Respect for autonomy Rational human being has inherent value A human being is not a means only to an end Beneficence Promotion and protection of human well being Provide opportunity for subjects to seek legal relief Justice Fair and equitable treatment of all human beings Protect rights to recover losses due to negligence Tissue obtained from you in this research may be used to establish a cell line that could be patented and licensed. There are no plans to provide financial compensation to you should this occur. By consenting to participate, you authorize the use of your bodily fluids a